Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction

This study has been terminated.

( Terminated October 2009 (in 4th year) due to low enrollment and anticipated drug expiration November 2009. )

Study NCT00487578 Information provided by Cady, Roger, M.D.

First Received on June 14, 2007. Last Updated on January 21, 2011 History of Changes

Results First Received: November 16, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Post Traumatic Headache
Intervention:	Drug: naratriptan HCl

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject enrollment started in 2006 at Site 1 (headache specialty clinic). Subjects were never enrolled at 2nd site (hospital rehabilitation center). Sites 3 (pain clinic) and 4 (hospital rehabilitation center) were added in 2008. Enrollment continued until study termination October 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
19 participants were screened. 7 were Screen Failures.

Reporting Groups

	Description
Active Naratriptan	Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
Placebo Matching Naratriptan	placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days

Participant Flow: Overall Study

	Active Naratriptan	Placebo Matching Naratriptan
STARTED	3	9
COMPLETED	2	5
NOT COMPLETED	1	4
Adverse Event	1	2
Lack of Efficacy	0	1
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
Active Naratriptan	Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
Placebo Matching Naratriptan	placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days

Baseline Measures

	Active Naratriptan	Placebo Matching Naratriptan	Total
Number of Participants [units: participants]	3	9	12
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	3	9	12
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	39.66 ± 10.96	37.22 ± 9.65	37.83 ± 9.53
Gender [units: participants]
Female	1	7	8
Male	2	2	4
Region of Enrollment [units: participants]
United States	3	9	12

Outcome Measures

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1. Primary:

Headache Days [ Time Frame: Day 30 ]

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2. Primary:

Headache Impact Test-6 (HIT-6) Score [ Time Frame: Day 0, Day 30 ]

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3. Primary:

Mental Efficiency Workload Test (MEWT) Performance Index Score [ Time Frame: Day 0, Day 10, Day 30 ]

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4. Secondary:

Overall Satisfaction With Medication Score [ Time Frame: Day 30, Day 90 ]

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5. Secondary:

Quality of Life Scores [ Time Frame: Day 0, Day 30, Day 90 ]

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6. Secondary:

Sustained Treatment Effect [ Time Frame: Day 0, Day 10, Day 30 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Publication of study data collected by Investigator is authorized subject to the following:Investigator is free to publish results of its part of study in collaboration with other investigators subsequent to the multicenter publication issued by Clinvest. If no multicenter publication is submitted within 12 months of end of study, investigator may publish results of its data. Investigator shall submit a copy of manuscript or abstract to Clinvest for review 30 days prior to journal submission.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated October 2009 (in 4th year) due to low enrollment and anticipated drug expiration November 2009 (study drug had previously been re-supplied at expiration of 1st batch November 2007). No analysis performed.

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Study terminated October 2009 (in 4th year) due to low enrollment and anticipated drug expiration November 2009 (study drug had previously been re-supplied at expiration of 1st batch November 2007).

No analysis performed.

Results Point of Contact:

Name/Title: M.E. Beach
Organization: Clinvest
phone: (417) 841-3618
e-mail: mbeach@clinvest.com

Publications:

Baandrup L, Jensen R. Chronic post-traumatic headache--a clinical analysis in relation to the International Headache Classification 2nd Edition. Cephalalgia. 2005 Feb;25(2):132-8. Erratum in: Cephalalgia. 2005 Mar;25(3):240.

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. No abstract available.

Responsible Party:	Cady, Roger, M.D./CEO, Clinvest
ClinicalTrials.gov Identifier:	NCT00487578 History of Changes
Other Study ID Numbers:	106542
Study First Received:	June 14, 2007
Results First Received:	November 16, 2009
Last Updated:	January 21, 2011
Health Authority:	United States: Food and Drug Administration