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CompletedNCT01657370Updated Dec 9, 2016Results posted

A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)

A Phase 2 interventional study of MK-1602 and Placebo in Migraine, sponsored by Allergan. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-12-09.

Sponsored by Allergan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
195
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the treatment of acute migraine, including the influence of demographic and other variables on MK-1602 pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and efficacy of the drug.

02

Conditions studied

  • Migraine

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 195 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • > 1 year history of migraine with or without aura as defined by International Headache Society (IHS) criteria 1.1 and/or 1.2
  • Migraines typically last between 4 to 72 hours, if untreated
  • ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in each of

the two months prior to screening

  • Male, female who is not of reproductive potential, or female of

reproductive potential with a screening serum β-human chorionic gonadotropin (β-hCG) level consistent with a not-pregnant state, and who agrees to use acceptable contraception

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
  • Participant has difficulty distinguishing his/her migraine attacks from tension-type headaches
  • History of predominantly mild migraine attacks or migraines that usually

resolve spontaneously in less than two hours

  • More than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the three months prior to screening
  • Basilar-type or hemiplegic migraine headache
  • > 50 years old at age of migraine onset
  • Taking migraine prophylactic medication where the prescribed daily dose

has changed during the 3 months prior to screening and during the study

  • Taking a proton pump inhibitor (PPI) or a histamine receptor 2 (H2) blocker on a daily or near daily basis (> 3 days per week)
  • Taking the following medications from 1 month prior to screening through study period: potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., cyclosporine, itraconazole, ketoconazole, fluconazole, erythromycin, clarithromycin, nefazodone, telithromycin, cimetidine, quinine, diltiazem, verapamil, modafinil and human immunodeficiency virus [HIV] protease inhibitors), moderate or marked CYP3A4 inducers (e.g., rifampicin, rifabutin, barbiturates [e.g., phenobarbital and primidone], systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, and St. Johns wort), or drugs with narrow therapeutic margins and potential for drug interactions in the CYP2C family (e.g., warfarin)
  • Participant is unable to refrain from consumption of grapefruit or grapefruit juice during study
  • History of hypersensitivity to, or has experienced a serious adverse event

in response to 3 or more classes of drugs (prescription and over-the-counter)

  • Clinical or laboratory evidence of uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease
  • Other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine. Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled are eligible to participate
  • Participant is at imminent risk of self-harm
  • History of malignancy ≤ 5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • History of gastric or small intestinal surgery (including gastric bypass

surgery or banding), or presence of a disease that causes malabsorption

  • History or current evidence of any condition, therapy, lab abnormality or

other circumstance that might confound the results of the study, or interfere with subject's participation for the full duration of the study

  • Participant has recent history (within the last year) of drug or alcohol abuse or dependence or is a user of recreational or illicit drugs
  • Participant is legally or mentally incapacitated
  • Donation of blood products or phlebotomy of > 300 ml within 8

weeks of study, or intent to donate blood products or receive

blood products within 30 days of screening and throughout study

  • Intent to donate eggs or sperm within the projected duration of the

study

  • Current participation in or participation within 30 days of screening

in a study with an investigational compound or device, with the exception of MK-1602 Protocol 006

  • Previous exposure to MK-0974 and/or MK-3207
  • Use within the past 2 months of an opioid- or barbiturate-containing

analgesic for migraine relief

  • Inpatient or emergency department treatment of an acute migraine

attack within the past 2 months

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
195 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.

    Drug: Placebo · Drug: Rescue medication

  • Experimental
    MK-1602 1 mg

    MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.

    Drug: MK-1602 · Drug: Rescue medication

  • Experimental
    MK-1602 10 mg

    MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.

    Drug: MK-1602 · Drug: Rescue medication

  • Experimental
    MK-1602 25 mg

    MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.

    Drug: MK-1602 · Drug: Rescue medication

  • Experimental
    MK-1602 50 mg

    MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.

    Drug: MK-1602 · Drug: Rescue medication

  • Experimental
    MK-1602 100 mg

    MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.

    Drug: MK-1602 · Drug: Rescue medication

Interventions

  • DrugMK-1602

    Three administrations of the same dose of MK-1602 on separate days. All 3 doses are either 1, 10, 25, 50 or 100 mg of MK-1602. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1). Dosage form is film coated tablet for oral administration.

  • DrugPlacebo

    Three administrations of placebo for MK-1602 on separate days. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1). Dosage form is film coated tablet for oral administration.

  • DrugRescue medication

    If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours, Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\]), anti-emetics, triptans, opiates or other medication not explicitly excluded.

06

What researchers measure

Primary outcomes

  1. Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day

    The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay.

    Time frame: 2 hours post dose 1

  2. Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day

    PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.

    Time frame: 2 hours post dose 1

  3. Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day

    PR was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.

    Time frame: 2 hours post dose 1

Secondary outcomes

  1. Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day

    Phonophobia is sensitivity to sound.

    Time frame: 2 hours post dose 1

  2. Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day

    Photophobia is sensitivity to light.

    Time frame: 2 hours post dose 1

  3. Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day

    Time frame: 2 hours post dose 1

  4. Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day

    SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 2-24 hour period after dosing with study medication.

    Time frame: 2-24 hours post dose 1

  5. Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day

    SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 2-24 hour period after dosing with study medication.

    Time frame: 2-24 hours post dose 1

  6. Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day

    TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.

    Time frame: 2 hours post dose 1

  7. Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day

    TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication.

    Time frame: 2-24 hours post dose 1

Other outcomes

  1. Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day

    Time frame: Up to 24 hours post dose 1

  2. Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)

    Time frame: 3.5 hours post dose 3

  3. Plasma MK-1602 Concentrations at Visit 2 (Day 4)

    Time frame: Up to 3.5 hours post dose 3

07

Results

Posted Dec 9, 2016

Participant flow

Participant flow — Overall Study
MilestonePlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Started333232333431
Completed272825282727
Not completed647574
Withdrew: Withdrawal by subject001001
Withdrew: Physician decision231250
Withdrew: Lack of qualifying event103212
Withdrew: Adverse event000010
Withdrew: Protocol violation111100
Withdrew: Lost to follow-up201001

Outcome measures

PrimaryDry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day

The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay.

Time frame:
2 hours post dose 1
Reported as:
Geometric mean · nanomolar (nM)
Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day
nanomolar (nM)MK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day1.9 ± 7317.0 ± 7443.8 ± 13052.7 ± 270184.8 ± 170
PrimaryPercentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day

PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.

Time frame:
2 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day0.0 (0.0 to 12.3)0.0 (0.0 to 12.3)3.8 (0.1 to 19.6)17.9 (6.1 to 36.9)28.6 (13.2 to 48.7)11.1 (2.4 to 29.2)
PrimaryPercentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day

PR was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.

Time frame:
2 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day42.9 (24.5 to 62.8)42.9 (24.5 to 62.8)30.8 (14.3 to 51.8)46.4 (27.5 to 66.1)67.9 (47.6 to 84.1)70.4 (49.8 to 86.2)
SecondaryPercentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day

Phonophobia is sensitivity to sound.

Time frame:
2 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day28.6 (13.2 to 48.7)42.9 (24.5 to 62.8)30.8 (14.3 to 51.8)42.9 (24.5 to 62.8)57.1 (37.2 to 75.5)44.4 (25.5 to 64.7)
SecondaryPercentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day

Photophobia is sensitivity to light.

Time frame:
2 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day25.0 (10.7 to 44.9)25.0 (10.7 to 44.9)26.9 (11.6 to 47.8)28.6 (13.2 to 48.7)46.4 (27.5 to 66.1)48.1 (28.7 to 68.1)
SecondaryPercentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day
Time frame:
2 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day67.9 (47.6 to 84.1)57.1 (37.2 to 75.5)69.2 (48.2 to 85.7)57.1 (37.2 to 75.5)82.1 (63.1 to 93.9)74.1 (53.7 to 88.9)
SecondaryPercentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day

SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 2-24 hour period after dosing with study medication.

Time frame:
2-24 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day0.0 (0.0 to 12.3)0.0 (0.0 to 12.3)3.8 (0.1 to 19.6)10.7 (2.3 to 28.2)14.3 (4.0 to 32.7)3.7 (0.1 to 19.0)
SecondaryPercentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day

SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 2-24 hour period after dosing with study medication.

Time frame:
2-24 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day28.6 (13.2 to 48.7)25.0 (10.7 to 44.9)15.4 (4.4 to 34.9)42.9 (24.5 to 62.8)57.1 (37.2 to 75.5)48.1 (28.7 to 68.1)
SecondaryPercentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day

TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.

Time frame:
2 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day0.0 (0.0 to 12.3)0.0 (0.0 to 12.3)0.0 (0.0 to 13.2)14.3 (4.0 to 32.7)28.6 (13.2 to 48.7)7.4 (0.9 to 24.3)
SecondaryPercentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day

TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication.

Time frame:
2-24 hours post dose 1
Reported as:
Number · percentage of participants
Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day
percentage of participantsPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day0.0 (0.0 to 12.3)0.0 (0.0 to 12.3)0.0 (0.0 to 13.2)10.7 (2.3 to 28.2)14.3 (4.0 to 32.7)3.7 (0.1 to 19.0)
Other pre-specifiedDry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day
Time frame:
Up to 24 hours post dose 1

No measurements were reported for this outcome.

Other pre-specifiedDry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)
Time frame:
3.5 hours post dose 3

No measurements were reported for this outcome.

Other pre-specifiedPlasma MK-1602 Concentrations at Visit 2 (Day 4)
Time frame:
Up to 3.5 hours post dose 3

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/28 (0%)6/28 (21.4%)
MK-1602 1 mg—0/28 (0%)6/28 (21.4%)
MK-1602 10 mg—0/26 (0%)2/26 (7.7%)
MK-1602 25 mg—0/28 (0%)10/28 (35.7%)
MK-1602 50 mg—0/28 (0%)7/28 (25%)
MK-1602 100 mg—0/27 (0%)7/27 (25.9%)
Most frequent other events
Most frequent other events
EventPlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mg
DizzinessNervous system disorders4/282/280/262/280/282/27
NauseaGastrointestinal disorders1/280/281/262/283/281/27
Abdominal pain upperGastrointestinal disorders0/281/280/260/282/282/27
NasopharyngitisInfections and infestations1/281/280/261/280/282/27
DiarrhoeaGastrointestinal disorders0/280/280/262/281/280/27
Dry mouthGastrointestinal disorders0/281/281/262/282/281/27
FatigueGeneral disorders1/280/280/262/280/280/27
HeadacheNervous system disorders0/282/280/260/280/280/27
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/280/280/262/280/280/27

Baseline characteristics

All Subjects as Treated Population included all randomized participants who received at least 1 dose of study treatment.

Age, Customized
Age, Customized(participants)PlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mgTotal
<20 years1100024
20 to 29 years486911947
30 to 39 years97776642
40 to 49 years99776644
50 to 59 years53434322
60 to 64 years0002013
>= 65 years0020103
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboMK-1602 1 mgMK-1602 10 mgMK-1602 25 mgMK-1602 50 mgMK-1602 100 mgTotal
Female252622232618140
Male32452925
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01657370
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Aug 6, 2012
Start date
Aug 2012
Primary completion
Nov 2012
Completion
Dec 2012
Results posted
Dec 9, 2016
Last update
Dec 9, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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