Trial · NCT01581281

The Childhood and Adolescent Migraine Prevention Study

NCT01581281, Phase 3, Terminated, Children's Hospital Medical Center, Cincinnati; results first posted 2017-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Childhood and Adolescent Migraine Prevention Study. Trials, record NCT01581281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01581281

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Childhood and Adolescent Migraine Prevention Study
NCT number: NCT01581281
Status: Terminated
Phases: Phase 3
Enrollment: 488 participants, actual
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Migraine, Migraine Disorders, Headache
Interventions: Amitriptyline, Topiramate, Placebo
First posted: 2012-04-20
Last updated: 2017-08-10
Results first posted: 2017-08-10

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days	4 week baseline period and last 4 weeks of the 24-week trial	The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight. For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups.
Secondary	Change in Absolute Headache Disability Score on PedMIDAS	baseline and 24 week endpoint	The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for: 1. Amitriptyline vs. Placebo 2. Topiramate vs. Placebo 3. Amitriptyline vs Topiramate
Secondary	Change in Number of Headache Days	4 week baseline period and last 4 weeks of the 24-week trial	This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between: 1. Amitriptyline vs. placebo 2. Topiramate vs. placebo 3. Amitriptyline vs. Topiramate
Secondary	Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase	24 weeks	To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups.
Secondary	Occurrence of Treatment Emergent Serious Adverse Events	24 weeks of the trial	To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days	4 week baseline period and last 4 weeks of the 24-week trial	The primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period between the participants receiving amitriptyline and participants receiving placebo.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Absolute Headache Disability Score on PedMIDAS	baseline and 24 week endpoint		units on a scale	MEAN
SECONDARY	Change in Number of Headache Days	4 week baseline period and last 4 weeks of the 24-week trial	The analysis population included all participants who had observed end-point data: 101 in the topiramate group, 59 in the placebo group, and104 in the amitriptyline group.	days	MEAN
SECONDARY	Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase	24 weeks	Tolerability was assessed for all participants included in the primary analysis. Of those randomized, 33 were not included in the primary analysis due to early trial closure.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Occurrence of Treatment Emergent Serious Adverse Events	24 weeks of the trial		serious adverse events	NUMBER

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days	Topiramate	72		Participants
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days	Placebo	40		Participants
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days	Amitriptyline	69		Participants
Change in Absolute Headache Disability Score on PedMIDAS	Topiramate	-26.8	Standard Deviation 27.5	units on a scale
Change in Absolute Headache Disability Score on PedMIDAS	Placebo	-22.6	Standard Deviation 29.42	units on a scale
Change in Absolute Headache Disability Score on PedMIDAS	Amitriptyline	-22.5	Standard Deviation 26.37	units on a scale
Change in Number of Headache Days	Topiramate	-6.7	Standard Deviation 4.99	days
Change in Number of Headache Days	Placebo	-5.9	Standard Deviation 6.96	days
Change in Number of Headache Days	Amitriptyline	-6.7	Standard Deviation 6.20	days
Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase	Topiramate	102		Participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate	145
Overall Study	STARTED	Placebo	72
Overall Study	STARTED	Amitriptyline	144
Overall Study	COMPLETED	Topiramate	130
Overall Study	COMPLETED	Placebo	66
Overall Study	COMPLETED	Amitriptyline	132
Overall Study	NOT COMPLETED	Topiramate	15
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Amitriptyline	12

Source ClinicalTrials.gov

Adverse events63

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Asphasia	Nervous system disorders	Topiramate	23	145	25
other	Asphasia	Nervous system disorders	Placebo	7	72	9
other	Asphasia	Nervous system disorders	Amitriptyline	13	144	16
other	Cognitive Disorder	Nervous system disorders	Topiramate	23	145	25
other	Cognitive Disorder	Nervous system disorders	Placebo	8	72	8
other	Cognitive Disorder	Nervous system disorders	Amitriptyline	14	144	18
other	Dizziness	Nervous system disorders	Topiramate	9	145	9
other	Dizziness	Nervous system disorders	Placebo	1	72	2
other	Dizziness	Nervous system disorders	Amitriptyline	3	144	3
other	Memory Impairment	Nervous system disorders	Topiramate	24	145	29

1 to 10 of 63Source ClinicalTrials.gov

See all 63 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate
Total, all-cause mortality	Placebo
Total, all-cause mortality	Amitriptyline
Total, other adverse events	Topiramate	111	145
Total, other adverse events	Placebo	51	72
Total, other adverse events	Amitriptyline	106	144
Total, serious adverse events	Topiramate	4	145
Total, serious adverse events	Placebo	2	72
Total, serious adverse events	Amitriptyline	6	144

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23594025	DERIVED	PubMed
27788026	DERIVED	PubMed
34404270	DERIVED	PubMed
34865085	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01NS076788	Amitriptyline and Topiramate in the Prevention of Childhood Migraine	POWERS, SCOTT W; HERSHEY, ANDREW D	CINCINNATI CHILDRENS HOSP MED CTR	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2011 to 2014

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01581281

GET https://conductscience.org/api/trials/v1/NCT01581281/events?page=2

API reference For AI assistants