Trial Outcomes & Findings for Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms (NCT NCT01641445)

NCT ID: NCT01641445

Last Updated: 2020-10-20

Results Overview

Percent drinking days at the target medication dose

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Study Weeks 5-8

Results posted on

2020-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Topiramate Topiramate (200 mg) taken orally daily	Sugar Pill Placebo ("sugar pill") taken orally daily
Overall Study STARTED	41	41
Overall Study COMPLETED	31	36
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topiramate n=41 Participants Topiramate (200 mg) taken orally daily	Sugar Pill n=41 Participants Placebo ("sugar pill") taken orally daily	Total n=82 Participants Total of all reporting groups
Age, Continuous	20.88 Years STANDARD_DEVIATION 2.08 • n=5 Participants	20.49 Years STANDARD_DEVIATION 2.05 • n=7 Participants	20.68 Years STANDARD_DEVIATION 2.06 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: Study Weeks 5-8

Percent drinking days at the target medication dose

Outcome measures

Outcome measures
Measure	Topiramate n=41 Participants Topiramate (200 mg) taken orally daily	Sugar Pill n=41 Participants Placebo ("sugar pill") taken orally daily
Alcohol Use	29.59 Percent of days Standard Deviation 19.55	27.08 Percent of days Standard Deviation 21.47

PRIMARY outcome

Timeframe: Study Weeks 5-8

Percent heavy drinking days at the target medication dose. Heavy drinking is defined as 4 or more standard alcoholic drinks per day for females and 5 or more standard drinks per day for males.

Outcome measures

Outcome measures
Measure	Topiramate n=41 Participants Topiramate (200 mg) taken orally daily	Sugar Pill n=41 Participants Placebo ("sugar pill") taken orally daily
Heavy Drinking Days	9.34 percentage of days Standard Deviation 10.99	6.78 percentage of days Standard Deviation 11.44

SECONDARY outcome

Timeframe: 6-month follow-up assessment

Percent drinking days at the 6-month follow-up assessment

Outcome measures

Outcome measures
Measure	Topiramate n=24 Participants Topiramate (200 mg) taken orally daily	Sugar Pill n=31 Participants Placebo ("sugar pill") taken orally daily
Alcohol Use	23.56 Percent of days Standard Deviation 17.11	21.75 Percent of days Standard Deviation 21.50

SECONDARY outcome

Timeframe: 12-month follow-up assessment

Percent drinking days at the 12-month follow-up assessment

Outcome measures

Outcome measures
Measure	Topiramate n=22 Participants Topiramate (200 mg) taken orally daily	Sugar Pill n=27 Participants Placebo ("sugar pill") taken orally daily
Alcohol Use	25.55 Percent of days Standard Deviation 22.03	21.93 Percent of days Standard Deviation 21.73

Adverse Events

Topiramate

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Robert Miranda

Brown University

Phone: 401.863.6658

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Topiramate n=41 participants at risk Topiramate (200 mg) taken orally daily	Sugar Pill n=41 participants at risk Placebo ("sugar pill") taken orally daily
General disorders Slow Thinking or Reactions	29.3% 12/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	7.3% 3/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Psychiatric disorders Nervousness	9.8% 4/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	4.9% 2/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Psychiatric disorders Anxiety	34.1% 14/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	9.8% 4/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Psychiatric disorders Difficulty with Memory	29.3% 12/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	9.8% 4/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Psychiatric disorders Word Finding Difficulties	31.7% 13/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	7.3% 3/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Fatigue	29.3% 12/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	19.5% 8/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Psychiatric disorders Difficulty with Concentration or Attention	31.7% 13/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	7.3% 3/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Psychiatric disorders Depression	9.8% 4/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	2.4% 1/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Psychiatric disorders Confusion	12.2% 5/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	2.4% 1/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Gastrointestinal disorders Nausea	24.4% 10/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	24.4% 10/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Weight Loss	31.7% 13/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	26.8% 11/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Decrease in Appetite	31.7% 13/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	14.6% 6/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Paresthesias	53.7% 22/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	4.9% 2/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Eye disorders Eye Problems	14.6% 6/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	4.9% 2/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Eye disorders Changes in Vision	14.6% 6/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	4.9% 2/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Runny Nose, Sinus Problems, Sneezing	34.1% 14/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	41.5% 17/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Injuries	12.2% 5/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	17.1% 7/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Headache	29.3% 12/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	31.7% 13/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Sore Throat	24.4% 10/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	19.5% 8/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
Gastrointestinal disorders Diarrhea	7.3% 3/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	0.00% 0/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Elevated Heart Rate	9.8% 4/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	0.00% 0/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Stomach Discomfort (Cramps/Bloated)	9.8% 4/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	0.00% 0/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Fever	7.3% 3/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	0.00% 0/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Cough	19.5% 8/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	22.0% 9/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Dizziness	29.3% 12/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	2.4% 1/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Difficulty with Coordination or Balance	14.6% 6/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	2.4% 1/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.
General disorders Drowsiness or Sleepiness	39.0% 16/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.	24.4% 10/41 • Adverse events were collected during the 8-week active medication (or placebo pill) period. The definitions of adverse event and serious advserse event are the same as those used by clinicaltrials.gov.