Evaluating Neuroprotection in Aneurysm Coiling Therapy (ENACT)

This study has been completed.

Sponsor:

Collaborator:

Arbor Vita Corporation

Information provided by (Responsible Party):

NoNO Inc.

ClinicalTrials.gov Identifier:

NCT00728182

First received: August 1, 2008

Last updated: August 9, 2013

Last verified: August 2013

History of Changes

Results First Received: May 8, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Stroke
Interventions:	Drug: NA-1 Drug: Placebo

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
Between September 16, 2008 and March 30, 2011, subjects were recruited to 10 hospitals in Canada and 3 in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 subjects were randomized into study but did not receive drug:5 due to do endovascular aneurysm repair, 3 due to inability to obtain a pre-procedure MRI,2 due to pre-procedure ECG showing a QTc interval > 450 ms, 1 due to a fatal aneurysm rupture before drug, and 1 due to refusal by anesthesiologist to give drug to a subject with severe COPD.

Reporting Groups

	Description
1 NA-1	20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier. NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion
2 Placebo	Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Description

1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo

Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Participant Flow: Overall Study

	1 NA-1	2 Placebo
STARTED	92	93
COMPLETED	89	90
NOT COMPLETED	3	3
Adverse Event	1	0
Lost to Follow-up	2	0
Death	0	2
Protocol Noncompliance	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
1 NA-1	20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier. NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion
2 Placebo	Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
Total	Total of all reporting groups

Description

1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo

Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Total

Total of all reporting groups

Baseline Measures

	1 NA-1	2 Placebo	Total
Overall Participants Analyzed [Units: Participants]	92	93	185

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	70	78	148
>=65 years	22	15	37

Age [Units: Years] Mean (Standard Deviation)	57.72 (10.6)	56.05 (10.3)	56.88 (10.5)

Gender [Units: Participants]
Female	64	68	132
Male	28	25	53

Region of Enrollment [Units: Participants]
United States	12	15	27
Canada	80	78	158

Outcome Measures

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1. Primary:

Volume of New FLAIR Lesions(MRI) [ Time Frame: Enrolment, Days 2-4 ]

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2. Secondary:

Number of New DWI Lesions (MRI) [ Time Frame: Enrolment, Day 2-4 ]

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3. Secondary:

Number of New FLAIR Lesions (MRI) [ Time Frame: Enrolment, Days 2-4 ]

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4. Secondary:

Volume of New DWI Lesions (MRI) [ Time Frame: Enrolment, Days 2-4 ]

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5. Secondary:

National Institutes of Health Stroke Scale (NIHSS). [ Time Frame: Enrolment, Day 30 ]

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6. Secondary:

Modified Rankin Scale (mRS). [ Time Frame: Enrolment, Day 30 ]

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7. Other Pre-specified:

Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects [ Time Frame: Enrolment, Days 2-4 ]

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8. Other Pre-specified:

Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects [ Time Frame: Enrolment, Day 2-4 ]

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9. Other Pre-specified:

Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects [ Time Frame: Enrolment, Day 2-4 ]

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10. Other Pre-specified:

Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects [ Time Frame: Enrolment, Day 2-4 ]

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11. Other Pre-specified:

National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects [ Time Frame: Enrolment, Day 30 ]

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12. Other Pre-specified:

Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects [ Time Frame: Enrolment, Day 30 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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: The Investigator shall have the right to publish any information after prior submittal to NoNO, where NoNO can request a hold for up to 60 days, provided that no publication shall disclose Proprietary Information other than Data containing the results of the Study. Investigators may not publish in the first 18 months after the close of the trial except within a publication representing all participating clinical sites.

Results Point of Contact:

Name/Title: Roberta Anderson, Vice President of Clinical Development
Organization: NoNO Inc.
phone: 613 833-1020
e-mail: randerson@nonoinc.ca

Publications of Results:

Hill MD, Martin RH, Mikulis D, Wong JH, Silver FL, Terbrugge KG, Milot G, Clark WM, Macdonald RL, Kelly ME, Boulton M, Fleetwood I, McDougall C, Gunnarsson T, Chow M, Lum C, Dodd R, Poublanc J, Krings T, Demchuk AM, Goyal M, Anderson R, Bishop J, Garman D, Tymianski M; ENACT trial investigators. Safety and efficacy of NA-1 in patients with iatrogenic stroke after endovascular aneurysm repair (ENACT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2012 Nov;11(11):942-50. doi: 10.1016/S1474-4422(12)70225-9. Epub 2012 Oct 8.

Responsible Party:	NoNO Inc.
ClinicalTrials.gov Identifier:	NCT00728182 History of Changes
Other Study ID Numbers:	3302 (NA-1-002)
Study First Received:	August 1, 2008
Results First Received:	May 8, 2013
Last Updated:	August 9, 2013

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